The present invention relates to radiodiagnostic test procedures in the clinical analysis of the gastrointestinal tract and, more specifically, to a gastric emptying kit for use in such procedures.
Various techniques for clinically testing the gastrointestinal tract are known, some of which involve the use of radioactive material. Technitium 99.sup.m is a commonly used radionuclide in nuclear medicine because of its favorable imaging characteristics. See, for example, U.S. Pat. No. 4,115,540.
A known gastro emptying procedure utilizing radioactive material in solid food is disclosed in U.S. Pat. No. 4,207,327. Also see Scintigraphic Evaluation of Gastric Emptying by Leon Malmud, Robert S. Fisher, Linda C. Knight and Elizabeth Rock; Seminars in Nuclear Medicine, Vol. XII, No. 2 (April, 1982), the text of which is incorporated herein by reference.
The known gastric emptying test procedures are not particularly favored by technologists and physicians at the present time because of a lack of overall standardization. For example, in the present practice, a technician must procure a specially prepared meal on the day of the examination. This, of course, creates difficulties in obtaining exact comparisons of a patient's most recent test with previous tests done at the same or other hospital. Studies of a variety of gastric disorders require that the test procedure be exactly the same, each time it is conducted. For example, in the I.sup.131 Hippuran Renogram, where blood and urine samples are taken at specific times and compared to an exact calculated standard, precise information is an absolute necessity.
The known procedures are also regarded as time consuming and messy, and involve the troublesome issue of waste disposal.
The present invention eliminates the above described problems by providing a standardized test package in kit form which includes everything necessary to perform the test with the exception of radioactive material, which is provided separately.
In one exemplary embodiment of the invention, a kit is provided which contains a package of freeze dried beef as the solid meal tracer. As will be explained in greater detail below, freeze dried beef was chosen because of its good labeling efficiency, i.e., it holds the radioactive material better than other previously used solid foods, and it does not dissociate into liquid during testing. In addition, the use of freeze dried, pre-cooked beef enhances standardization, and is easy to prepare. Freeze dried beef is also preferred by many people over previously used solid foods such as chicken livers and/or scrambled eggs.
The kit in accordance with this invention also contains one (1) small plastic container provided with injection port means; one (1) large plastic combination mixing and serving container; one (1) can of beef stew; one (1) package containing a napkin, radiacwash towelette and plastic spoon (for mixing and serving); one (1) plastic bag for containment and disposal of radioactive waste; one (1) absorbant pad for patient use; radioactive material labels; and instructions for preparation.
A further aspect of the invention relates to a procedure for preparing and carrying out a gastric emptying process utilizing the above described kit. In an exemplary embodiment, the process includes the steps of:
(a) cutting open the package of freeze dried beef; placing a portion of the beef in the small tagging container until level with a black line indicated on the side of the container; placing a top on container, and discarding the unused portion of the beef.
(b) with a sterile lead-shielded 30 cc syringe, aseptically obtaining one (1) millicurie of Tc.sup.99m Sulfur Colloid;
(c) using the same 30 cc syringe of Sulfur Colloid, drawing up the remaining volume of the syringe with warm sterile water;
(d) behind lead shielding, injecting the 30 cc Sulfur Colloid 1mCi) and warm sterile water into the small tagging container containing the freeze-dried beef via the injection port, and labeling the container as radioactive;
(e) allowing about five minutes for the radioactive material to be absorbed into the meat, while occasionally shaking the container to insure even distribution;
(f) after making sure that all the liquid has been absorbed, carefully opening the small tagging container and pouring the radio-labeled beef into the large plastic serving container;
(g) opening the can of beef stew provided, and carefully adding it to the serving container of the now radioactive labeled beef;
(h) placing the container in a microwave oven for approximately one minute, or until warm;
(i) stirring with the plastic serving utensil and then serving it to the patient;
(j) placing all contaminated materials into the plastic bag provided, storing in a shielded area until residual activity has decayed to background level, and thereafter disposing of the bag and its contents.
The gastric emptying kit in accordance with this invention has the following advantages:
1. One Convenient Package: With the exception of the radioactive isotope, all the items necessary to perform the gastric emptying procedure are contained in one package.
2. Ease of Preparation: This kit is as easy to prepare as most other radiopharmaceuticals. No cooking is required. Just warm and serve.
3. Reduced Isotopic Contamination: This procedure, which uses dried beef, compared to other solid meals now being used (e.g., scrambled eggs and chicken livers) reduces possible contamination because of two of the main features of this kit, Item 2 above and Item 7 below. When the actual time required in dealing with the isotope itself is reduced, so also will the radiation risk to the technologist. This radiation safety factor is in itself a very advantageous feature.
4. High Patient Acceptability: Most people surveyed prefer roast beef over scrambled eggs or chicken livers.
5. Standardization of Gastric Testing: The ease of preparation, and the exact meal amounts in each kit allows the test to be reproduced accurately and efficiently. Patients can thus be rescanned many times without the worry of differences in preparation, meal types, or amounts--all of which would affect gastric emptying times.
6. Long Shelf Life: Since freeze dried meat can be stored for long periods, the kit of this invention can be stored on the shelf until ready for use. This eliminates the necessity of procuring a solid meal on the day of the examination.
7. Easy Clean-Up: Everything contained in the Gastrotec Kit is disposable. All contaminated containers and utensils can be placed in the plastic bag provided and stored in a designated waste area for a few days. When the waste has decayed to an acceptable background level, it can then be surveyed and disposed of in normal trash.
Additional objects and advantages will become apparent from the detailed description which follows.